Method and apparatus for fitting a visual prosthesis using electrically evoked responses

ABSTRACT

The invention is a method of automatically adjusting a visual prosthesis electrode array to the neural characteristics of an individual patient. By recording electrically evoked responses to a predetermined input stimulus, one can alter that input stimulus to the needs of an individual patient. A minimum input stimulus is applied to a patient, followed by recording an electrically evoked response to the input stimulus. By gradually increasing stimulus levels, one can determine the minimum input that creates a neural response, thereby identifying the threshold stimulation level. One can further determine a maximum level by increasing stimulus until a predetermined maximum neural response is obtained.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/311,264, filed Dec. 5, 2011, to be issued as U.S. Pat. No.10,292,579, for Method and Apparatus for Fitting a Visual ProsthesisUsing Electrically Evoked Electroretinograms, which claims the benefitof U.S. provisional Patent Application Ser. No. 61/419,663, filed Dec.3, 2010 for Fitting a Visual Prosthesis using Electrically EvokedElectroretinograms, the disclosure of which is incorporated herein byreference. This application is also related U.S. Pat. No. 7,483,751,Automatic Fitting for a Visual Prosthesis, the disclosure of which isincorporated by Reference.

FIELD

The present disclosure relates to visual prostheses configured toprovide neural stimulation for the creation of artificial vision.

BACKGROUND

In 1755 LeRoy passed the discharge of a Leyden jar through the orbit ofa man who was blind from cataract and the patient saw “flames passingrapidly downwards.” Ever since, there has been a fascination withelectrically elicited visual perception. The general concept ofelectrical stimulation of retinal cells to produce these flashes oflight or phosphenes has been known for quite some time. Based on thesegeneral principles, some early attempts at devising a prosthesis foraiding the visually impaired have included attaching electrodes to thehead or eyelids of patients. While some of these early attempts met withsome limited success, these early prosthetic devices were large, bulkyand could not produce adequate simulated vision to truly aid thevisually impaired.

In the early 1930's, Foerster investigated the effect of electricallystimulating the exposed occipital pole of one cerebral hemisphere. Hefound that, when a point at the extreme occipital pole was stimulated,the patient perceived a small spot of light directly in front andmotionless (a phosphene). Subsequently, Brindley and Lewin (1968)thoroughly studied electrical stimulation of the human occipital(visual) cortex. By varying the stimulation parameters, theseinvestigators described in detail the location of the phosphenesproduced relative to the specific region of the occipital cortexstimulated. These experiments demonstrated: (1) the consistent shape andposition of phosphenes; (2) that increased stimulation pulse durationmade phosphenes brighter; and (3) that there was no detectableinteraction between neighboring electrodes which were as close as 2.4 mmapart.

As intraocular surgical techniques have advanced, it has become possibleto apply stimulation on small groups and even on individual retinalcells to generate focused phosphenes through devices implanted withinthe eye itself. This has sparked renewed interest in developing methodsand apparatuses to aid the visually impaired. Specifically, great efforthas been expended in the area of intraocular visual prosthesis devicesin an effort to restore vision in cases where blindness is caused byphotoreceptor degenerative retinal diseases such as retinitis pigmentosaand age related macular degeneration which affect millions of peopleworldwide.

Neural tissue can be artificially stimulated and activated by prostheticdevices that pass pulses of electrical current through electrodes onsuch a device. The passage of current causes changes in electricalpotentials across visual neuronal membranes, which can initiate visualneuron action potentials, which are the means of information transfer inthe nervous system.

Based on this mechanism, it is possible to input information into thenervous system by coding the information as a sequence of electricalpulses which are relayed to the nervous system via the prostheticdevice. In this way, it is possible to provide artificial sensationsincluding vision.

One typical application of neural tissue stimulation is in therehabilitation of the blind. Some forms of blindness involve selectiveloss of the light sensitive transducers of the retina. Other retinalneurons remain viable, however, and may be activated in the mannerdescribed above by placement of a prosthetic electrode device on theinner (toward the vitreous) retinal surface (epiretinal). This placementmust be mechanically stable, minimize the distance between the deviceelectrodes and the visual neurons, and avoid undue compression of thevisual neurons.

In 1986, Bullara (U.S. Pat. No. 4,573,481) patented an electrodeassembly for surgical implantation on a nerve. The matrix was siliconewith embedded iridium electrodes. The assembly fit around a nerve tostimulate it.

Dawson and Radtke stimulated cats' retina by direct electricalstimulation of the retinal ganglion cell layer. These experimentersplaced nine and then fourteen electrodes upon the inner retinal layer(i.e., primarily the ganglion cell layer) of two cats. Their experimentssuggested that electrical stimulation of the retina with 30 to 100 uAcurrent resulted in visual cortical responses. These experiments werecarried out with needle-shaped electrodes that penetrated the surface ofthe retina (see also U.S. Pat. No. 4,628,933 to Michelson).

The Michelson '933 apparatus includes an array of photosensitive deviceson its surface that are connected to a plurality of electrodespositioned on the opposite surface of the device to stimulate theretina. These electrodes are disposed to form an array similar to a “bedof nails” having conductors which impinge directly on the retina tostimulate the retinal cells. U.S. Pat. No. 4,837,049 to Byers describesspike electrodes for neural stimulation. Each spike electrode piercesneural tissue for better electrical contact. U.S. Pat. No. 5,215,088 toNormann describes an array of spike electrodes for cortical stimulation.Each spike pierces cortical tissue for better electrical contact.

The art of implanting an intraocular prosthetic device to electricallystimulate the retina was advanced with the introduction of retinal tacksin retinal surgery. De Juan, et al. at Duke University Eye Centerinserted retinal tacks into retinas in an effort to reattach retinasthat had detached from the underlying choroid, which is the source ofblood supply for the outer retina and thus the photoreceptors. See,e.g., E. de Juan, et al., 99 Am. J. Ophthalmol. 272 (1985). Theseretinal tacks have proved to be biocompatible and remain embedded in theretina and choroid/sclera, effectively pinning the retina against thechoroid and the posterior aspects of the globe. Retinal tacks are oneway to attach a retinal array to the retina. U.S. Pat. No. 5,109,844 tode Juan describes a flat electrode array placed against the retina forvisual stimulation. U.S. Pat. No. 5,935,155 to Humayun describes avisual prosthesis for use with the flat retinal array described in deJuan.

A visual prosthesis must be adjusted to an individual patient. The mostbasic adjustment is mapping brightness levels to stimulation intensity,as this varies from patient to patient and from electrode to electrodefor an individual patient. Hence, the visual prosthesis must be fit tothe patient. As the number of active electrodes in a visual prosthesisincreases, manually adjusting or fitting the visual prosthesis becomestedious or impossible. Automatic fitting techniques are known such asthose described in U.S. Pat. No. 7,483,751, Greenberg et al, AutomaticFitting for a Visual Prosthesis. Greenberg describes automatic fittingusing iris sphincter response, retinal recordings and corticalrecordings. These techniques are effective but very expensive toimplement.

SUMMARY

The invention is a method of automatically adjusting a retinal electrodearray to the neural characteristics of an individual patient. Byrecording electrically evoked electroretinogram (eERG) responses to apredetermined input stimulus, one can alter that input stimulus to theneeds of an individual patient. A minimum input stimulus is applied to apatient, while simultaneously recording an eERG containing the responseto the input stimulus. By repeating stimulation and recording atgradually increasing stimulus levels, one can determine the minimuminput that creates a neural response, thereby identifying the thresholdstimulation level. One can further determine a maximum level byincreasing stimulus until a predetermined maximum neural response isobtained. However, eERG signals include a significant amount of noise.Applicants have developed novel techniques for artifact reduction andnoise filtering to provide an accurate measure of neural activity.

According to a first aspect of the invention, a method of fitting avisual prosthesis is proposed, including stimulating visual neurons withan electrical signal, detecting an indication of neural activity usingan electroretinogram, comparing the indication of neural activity to adesired level of neural activity, and altering the electrical signalbased upon a comparison of the indication of neural activity and thedesired level of neural activity.

According to a second aspect of the invention, the method according toaspect one, further includes applying a wavelet transform to theindication of neural activity

According to a third aspect of the invention, the method furtherincludes detecting an indication of neural activity in the fellow eyeusing an electroretinogram and subtracting the indication of neuralactivity in the fellow eye from the indication of neural activity in theimplanted eye.

According to a fourth aspect of the invention, the method according toaspect one, wherein the step of stimulating visual neurons includesincreasing the electrical charge until an indication of neural activityis detected.

Further embodiments are shown in the specification, drawings and claimsof the present application.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a flow chart showing the method of processing eERG signals.

FIG. 2 is a flow chart showing the process of auto fitting an electrodearray.

FIG. 3 depicts a block diagram of the visual prosthesis electroniccontrol unit.

FIG. 4 is a graph depicting a typical neural response to electricalinput.

FIGS. 5 and 6 show a retinal stimulation system adapted to be implantedinto a subject.

FIGS. 7 and 8 show a video capture/transmission apparatus or visoradapted to be used in combination with the retinal stimulation of FIGS.5 and 6.

FIG. 9 shows components of a fitting system according to the presentdisclosure, the system also comprising the visor shown in FIGS. 4 and 5.

FIG. 10 shows the visual prosthesis apparatus in a stand-alone mode,i.e. comprising the visor connected to a video processing unit.

FIGS. 11-12 show the video processing unit already briefly shown withreference to FIG. 9.

FIG. 13a shows a LOSS OF SYNC mode.

FIG. 13b shows an exemplary block diagram of the steps taken when VPUdoes not receive back telemetry from the Retinal stimulation system.

FIG. 13c shows an exemplary block diagram of the steps taken when thesubject is not wearing Glasses.

FIGS. 14-1, 14-2, 14-3 and 14-4 show an exemplary embodiment of a videoprocessing unit. FIG. 14-1 should be viewed at the left of FIG. 14-2.FIG. 14-3 should be viewed at the left of FIG. 14-4. FIGS. 14-1 and 14-2should be viewed on top of FIGS. 14-3 and 14-4.

In the following description, like reference numbers are used toidentify like elements. Furthermore, the drawings are intended toillustrate major features of exemplary embodiments in a diagrammaticmanner. The drawings are not intended to depict every feature of everyimplementation nor relative dimensions of the depicted elements, and arenot drawn to scale.

DETAILED DESCRIPTION

The present disclosure is concerned with a visual apparatus and a methodfor creation of artificial vision. In particular, the present disclosureprovides a means of automatically fitting a visual prosthesis using aneERG.

Subjects implanted with an Argus® II retinal prosthesis in the right eye(OD) participated in a study. Binocular eERGs were obtained, usingBurian-Allen contact lens electrodes, by averaging up to 2750 epochs.Current levels ranged from below perceptual threshold to a maximum of˜50 μA per electrode. Signal-to-noise ratios of raw eERGs were increasedoff-line using wavelet transformation (WT), for example the symlet 5transform. The eERG was expected to be measurable only in OD. Eyemovements and pupil responses may contribute to the eERG, but will alsoevoke a response in the contralateral or fellow eye (OS), since they arecentrally controlled. Therefore, pupil and eye movements were recordedwith an eye tracker, averaging up to 30 responses;

eERG responses were recorded, which consisted of a negative peak (N₁)followed by a positive peak (P₁). In most subjects eERGs can be obtainedbilaterally. We performed eye tracking and eERG recordings before andafter eye dilation with tropicamide (1%) and phenylephrin (2.5%). At 30μA, the pupil dilated in both eyes at 0.6 s, followed by a bilateralconstriction after 1.2 s, with smaller amplitudes in the implanted thanin the fellow eye (−0.1, +0.3 vs. −0.2, +0.5 mm). Pharmacologic dilationabolished these pupil responses. Eye movements were small (0.1 mm orless). Before dilation, the eERG N₁-P₁ amplitude was 6 μV in both eyes.After dilation, the eERG amplitude was 2 μV in both eyes. To removebilateral electrically evoked artifacts we subtracted the OS eERG fromthe OD eERG. No dilation drops were applied. Using this subtractionprocedure we obtained reliable eERGs. At current levels betweenperceptual threshold and maximum comfort level, eERG amplitudes were 2-5μV, N₁ latencies were 100-200 ms, and P₁ latencies 300-400 ms. eERGamplitudes correlated significantly (F-test, P<0.05, r²>0.9) withstimulus level.

Bilateral artifacts, such as pupil responses, in the corneal eERG cannotbe sufficiently reduced by using dilation drops. Even after dilation, aresidual, but substantial electrical response persisted in thecontralateral eye. This residual activity might reflect the neuralcomponent of the pupil reflex, while the myogenic component is blockedafter dilation. Subtracting the contralateral eERG yields the bestapproximation of the eERG.

FIG. 1 shows the filtering process applied to the eERG signal accordingto the present invention. Simultaneously, eERG signals are recorded inthe stimulated eye and the fellow eye 114. Visual neurons are stimulatedusing the visual prosthesis 116. eERG recording stops 118. Temporalalignment of the two eERG signals and the stimulus is important toremove the unwanted signal components. Next, a stationary wavelettransform, for example a symlet 5 transform, is applied to the eERGsignal from both eyes to filter out any artifact caused by the implantedelectronics 120. Particularly, the telemetry coils of the visualprosthesis generate substantial noise. Next, the eERG signal from thefellow eye is subtracted from the eERG signal from the stimulated eye122 to reduce biological artifacts, such as those associated with eyemovement and pupil responses. Since, both eyes move together and bothpupils respond together, subtracting the signal from the fellow eyeremoves the eye movement and pupil response artifacts. Next, eERGwaveforms with a peak-to-peak amplitude exceeding a predetermined levelin the first second are discarded 124. This eliminates those responseswith large artifacts that are not bilaterally symmetrical. Thepredetermined level is between 40 μV and 60 μV, but preferably 50 μV.Last, 100 to 200 epochs are averaged 126 to reduce random noise, such asbackground noise and small eye movements. Finally, the output isreturned and used the fitting process as described with respect to FIG.2 in step 128 of FIG. 1.

FIG. 2 is a flow chart of the automatic fitting sequence. In the flowchart, the value N is the initial selected electrode, X is the neuralactivity recorded, and L is the level of stimulation. First L is set to0, or some level known to be below the threshold of perception 140 andthen incremented 142. Electrode N is addressed 144. The stimulationlevel is set to zero 146, and then incremented 148. The neural tissue isstimulated at the minimum level 150. The stimulation is immediatelyfollowed by a recording of activity in the eERG 152. One must be carefulto distinguish between neural activity and electrical charge from thestimulating electrode. The neural response follows stimulation (see FIG.4). Simultaneous stimulation and recording requires that the recordingphase be longer than the stimulation phase. If so, the stimulation andneural response can be separated digitally. If the recorded neuralactivity is less than a predetermined level 154, the stimulation levelis increased and steps 148-154 are repeated. While this is preferably afully automatic process, it may be advantageous to first fit a subset ofthe electrodes using patient responses to properly calibrate the desiredeERG signal levels.

Once minimum neural activity is recorded, the stimulation level is savedin memory 156. The level is then further increased 158 and stimulationis repeated 160. Again stimulation is immediately followed by recordingneural activity 162. If a predetermined maximum level has not beenreached, steps 158-164 are repeated until the predetermined maximumstimulation level is obtained. Once the predetermined maximumstimulation level is obtained, steps 142-164 are repeated for the nextelectrode. The process is continued until a minimum and maximumstimulation level is determined for each electrode 166.

The maximum stimulation level borders on discomfort for the patient.Because the automatic fitting process is automated, high levels ofstimulation are only applied for a few microseconds. This significantlydecreases the level of discomfort for the patient compared withstimulating long enough to elicit a response from the patient.

The fitting process is described above as an incremental process. Thefitting process may be expedited by more efficient patterns. For examplechanges may be made in large steps if it the detected response issignificantly below the desired response, followed by increasingly smallsteps as the desired response draws near. The system can jump above andbelow the desired response dividing the change by half with each step.

Often, neural response in a retina is based, in part, geographically.That is, neurons closer to the fovea require less stimulation thanneurons farther from the fovea. Stimulation levels are also higher whenthe electrodes array does not contact the retina. Hence once astimulation is level is set for an electrode, one can presume that thelevel will be similar for an adjacent electrode. The fitting process maybe expedited by starting at a level near the level set for a previouslyfit adjacent electrode.

Automating the fitting process has many advantages. It greatly expeditesthe process reducing the efforts of the patient and clinician. Further,the automated process is objective. Patient responses are subjective andmay change over time due to fatigue. In some cases, a patient may not beable to provide the required responses due to age, disposition, and/orlimited metal ability.

FIG. 3 depicts a block diagram of the control unit. The block diagram isa functional diagram. Many of the functional units would be implementedin a microprocessor. A control unit 180 sets and increments a counter182 to control the stimulation level of the stimulator 184. Thestimulation signal is multiplexed in MUX 186 to address individualelectrodes 188. After each stimulation step, the eERG returns a neuralactivity signal to a recorder 190. The signal is compared to the storedminimum or maximum level (stored in a memory 192) in a comparator 194.After programming, a signal from a video source 196, or other neuralstimulation source, is adjusted in a mapping unit 198, in accordancewith the minimum and maximum levels stored in the memory 192. Theadjusted signal is sent to the stimulator 184, which in synchronizationwith MUX 186 applies the signal to the electrodes 188. The electronicsfor the control unit could be external or within the implantedprosthesis.

FIG. 4 is a graphical representation of the neural response toelectrical stimulus. The vertical axis is current while the horizontalaxis is time. Four curves 100-106 show the response at varying inputcurrent levels. An input pulse 108, is followed by a brief delay 110,and a neural response 112. Hence, it is important to properly time thedetecting function. It should also be noted that the delay period 110becomes shorter with increased stimulation current. Hence, the systemmust separate the stimulation signals and neural response faster withincreased current. The change in delay time may also be used as anadditional indication of neural response. That is, the minimum andmaximum may be determined by matching predetermined delay times ratherthan predetermined output levels.

The exemplary retinal stimulation system shown in FIGS. 5 and 6, is animplantable electronic device containing an inductive coil 16 and anelectrode array 10 that is electrically coupled by a cable 48 thatpierces sclera of the subject's eye to an electronics package 14,external to the sclera. The retinal stimulation system is designed, forexample, to elicit visual percepts in blind subjects with retinitispigmentosa.

Human vision provides a field of view that is wider than it is high.This is partially due to fact that we have two eyes, but even a singleeye provides a field of view that is approximately 90° high and 140° to160° degrees wide. It is therefore, advantageous to provide a flexiblecircuit electrode array 10 that is wider than it is tall. This isequally applicable to a cortical visual array. In which case, the widerdimension is not horizontal on the visual cortex, but corresponds tohorizontal in the visual scene.

FIGS. 5 and 6 present the general structure of a visual prosthesis usedin implementing the invention.

FIG. 5 shows a perspective view of the implanted portion of thepreferred retinal prosthesis. A flexible circuit 1 includes a flexiblecircuit electrode array 10 which is mounted by a retinal tack (notshown) or similar means to the epiretinal surface. The flexible circuitelectrode array 10 is electrically coupled by a flexible circuit cable12, which pierces the sclera and is electrically coupled to anelectronics package 14, external to the sclera.

The electronics package 14 is electrically coupled to a secondaryinductive coil 16. Preferably the secondary inductive coil 16 is madefrom wound wire. Alternatively, the secondary inductive coil 16 may bemade from a flexible circuit polymer sandwich with wire traces depositedbetween layers of flexible circuit polymer. The secondary inductive coilreceives power and data from a primary inductive coil 17, which isexternal to the body. The electronics package 14 and secondary inductivecoil 16 are held together by the molded body 18. The molded body 18holds the electronics package 14 and secondary inductive coil 16 end toend. The molded body 18 holds the secondary inductive coil 16 andelectronics package 14 in the end to end orientation and minimizes thethickness or height above the sclera of the entire device. The moldedbody 18 may also include suture tabs 20. The molded body 18 narrows toform a strap 22 which surrounds the sclera and holds the molded body 18,secondary inductive coil 16, and electronics package 14 in place. Themolded body 18, suture tabs 20 and strap 22 are preferably an integratedunit made of silicone elastomer. Silicone elastomer can be formed in apre-curved shape to match the curvature of a typical sclera. However,silicone remains flexible enough to accommodate implantation and toadapt to variations in the curvature of an individual sclera. Thesecondary inductive coil 16 and molded body 18 are preferably ovalshaped. A strap 22 can better support an oval shaped coil. It should benoted that the entire implant is attached to and supported by thesclera. An eye moves constantly. The eye moves to scan a scene and alsohas a jitter motion to improve acuity. Even though such motion isuseless in the blind, it often continues long after a person has losttheir sight. By placing the device under the rectus muscles with theelectronics package in an area of fatty tissue between the rectusmuscles, eye motion does not cause any flexing which might fatigue, andeventually damage, the device.\

FIG. 6 shows a side view of the implanted portion of the retinalprosthesis, in particular, emphasizing the fan tail 24. When implantingthe retinal prosthesis, it is necessary to pass the strap 22 under theeye muscles to surround the sclera. The secondary inductive coil 16 andmolded body 18 must also follow the strap 22 under the lateral rectusmuscle on the side of the sclera. The implanted portion of the retinalprosthesis is very delicate. It is easy to tear the molded body 18 orbreak wires in the secondary inductive coil 16. In order to allow themolded body 18 to slide smoothly under the lateral rectus muscle, themolded body 18 is shaped in the form of a fan tail 24 on the endopposite the electronics package 14. The strap 22 further includes ahook 28 the aids the surgeon in passing the strap under the rectusmuscles.

Referring to FIGS. 7 and 8, the glasses 5 may comprise, for example, aframe 11 holding a camera 13, an external coil 17 and a mounting system19 for the external coil 17. The mounting system 19 may also enclose theRF circuitry. In this configuration, the video camera 13 captures livevideo. The video signal is sent to an external Video Processing Unit(VPU) 20 (shown in FIGS. 9, 11 and 12 and discussed below), whichprocesses the video signal and subsequently transforms the processedvideo signal into electrical stimulation patterns or data. Theelectrical stimulation data are then sent to the external coil 17 thatsends both data and power via radio-frequency (RF) telemetry to the coil16 of the retinal stimulation system, shown in FIGS. 5 and 6. The coil16 receives the RF commands which control an application specificintegrated circuit (ASIC) which in turn delivers stimulation to theretina of the subject via a thin film electrode array (TFEA). In oneaspect of an embodiment, light amplitude is recorded by the camera 13.The VPU 20 may use a logarithmic encoding scheme to convert the incominglight amplitudes into the electrical stimulation patterns or data. Theseelectrical stimulation patterns or data may then be passed on to theRetinal Stimulation System, which results in the retinal cells beingstimulated via the electrodes in the electrode array 10 (shown in FIGS.5 and 6). In one exemplary embodiment, the electrical stimulationpatterns or data being transmitted by the external coil 17 is binarydata. The external coil 17 may contain a receiver and transmitterantennae and a radio-frequency (RF) electronics card for communicatingwith the internal coil 16.

Referring to FIG. 9, a Fitting System (FS) may be used to configure andoptimize the visual prosthesis apparatus. The Fitting System is fullydescribed in the related application U.S. application Ser. No.11/796,425, filed on Apr. 27, 2007, which is incorporated herein byreference in its entirety.

The Fitting System may comprise custom software with a graphical userinterface running on a dedicated laptop computer 21. Within the FittingSystem are modules for performing diagnostic checks of the implant,loading and executing video configuration files, viewing electrodevoltage waveforms, and aiding in conducting psychophysical experiments.A video module can be used to download a video configuration file to theVideo Processing Unit (VPU) 20 discussed above and store it innon-volatile memory to control various aspects of video configuration,e.g. the spatial relationship between the video input and theelectrodes. The software can also load a previously used videoconfiguration file from the VPU 20 for adjustment.

The Fitting System can be connected to the Psychophysical Test System(PTS), located for example on a dedicated laptop 30, in order to runpsychophysical experiments. In psychophysics mode, the Fitting Systemenables individual electrode control, permitting clinicians to constructtest stimuli with control over current amplitude, pulse-width, andfrequency of the stimulation. In addition, the psychophysics moduleallows the clinician to record subject responses. The PTS may include acollection of standard psychophysics experiments developed using forexample MATLAB® (MathWorks®) software and other tools to allow theclinicians to develop customized psychophysics experiment scripts.

Using the psychophysics module, important perceptual parameters such asperceptual threshold, maximum comfort level, and spatial location ofpercepts may be reliably measured. Based on these perceptual parameters,the fitting software enables custom configuration of the transformationbetween video image and spatio-temporal electrode stimulation parametersin an effort to optimize the effectiveness of the retinal prosthesis foreach subject.

The Fitting System laptop 21 of FIG. 9 may be connected to the VPU 20using an optically isolated serial connection adapter 40. Because it isoptically isolated, the serial connection adapter 40 assures that noelectric leakage current can flow from the Fitting System laptop 10 inthe event of a fault condition.

As shown in FIG. 9, the following components may be used with theFitting System according to the present disclosure. The Video ProcessingUnit (VPU) 20 for the subject being tested, a Charged Battery 25 for VPU20, the Glasses 5, a Fitting System (FS) Laptop 10, a PsychophysicalTest System (PTS) Laptop 30, a PTS CD (not shown), a CommunicationAdapter (CA) 40, a USB Drive (Security) (not shown), a USB Drive(Transfer) 47, a USB Drive (Video Settings) (not shown), a Patient InputDevice (RF Tablet) 50, a further Patient Input Device (Jog Dial) 55,Glasses Cable 15, CA-VPU Cable 70, FS-CA Cable 45, FS-PTS Cable 46, Four(4) Port USB Hub 47, Mouse 60, Test Array system 80, Archival USB Drive49, an Isolation Transformer (not shown), adapter cables (not shown),and an External Monitor (not shown).

With continued reference to FIG. 9, the external components of theFitting System may be configured as follows. The battery 25 is connectedwith the VPU 20. The PTS Laptop 30 is connected to FS Laptop 10 usingthe FS-PTS Cable 46. The PTS Laptop 30 and FS Laptop 10 are plugged intothe Isolation Transformer (not shown) using the Adapter Cables (notshown). The Isolation Transformer is plugged into the wall outlet. Thefour (4) Port USB Hub 47 is connected to the FS laptop 10 at the USBport. The mouse 60 and the two Patient Input Devices 50 and 55 areconnected to four (4) Port USB Hubs 47. The FS laptop 10 is connected tothe Communication Adapter (CA) 40 using the FS-CA Cable 45. The CA 40 isconnected to the VPU 20 using the CA-VPU Cable 70. The Glasses 5 areconnected to the VPU 20 using the Glasses Cable 15.

In one exemplary embodiment, the Fitting System shown in FIG. 9 may beused to configure system stimulation parameters and video processingstrategies for each subject outfitted with the visual prosthesisapparatus. The fitting application, operating system, laptops 21 and 30,isolation unit and VPU 20 may be tested and configuration controlled asa system. The software provides modules for electrode control, allowingan interactive construction of test stimuli with control over amplitude,pulse width, and frequency of the stimulation waveform of each electrodein the Retinal stimulation system. These parameters are checked toensure that maximum charge per phase limits, charge balance, and powerlimitations are met before the test stimuli are presented to thesubject. Additionally, these parameters may be checked a second time bythe VPU 20's firmware. The Fitting System shown in FIG. 9 may alsoprovide a psychophysics module for administering a series of previouslydetermined test stimuli to record subject's responses. These responsesmay be indicated by a keypad 50 and/or verbally. The psychophysicsmodule may also be used to reliably measure perceptual parameters suchas perceptual threshold, maximum comfort level, and spatial location ofpercepts. These perceptual parameters may be used to custom configurethe transformation between the video image and spatio-temporal electrodestimulation parameters thereby optimizing the effectiveness of thevisual prosthesis for each subject. The Fitting System is fullydescribed in the related application U.S. application Ser. No.11/796,425, filed on Apr. 27, 2007, which is incorporated herein byreference in its entirety.

The visual prosthesis apparatus may operate in two modes: i) stand-alonemode and ii) communication mode.

Stand-Alone Mode

Referring to FIG. 10, in the stand-alone mode, the video camera 13, onthe glasses 5, captures a video image that is sent to the VPU 20. TheVPU 20 processes the image from the camera 13 and transforms it intoelectrical stimulation patterns that are transmitted to the externalcoil 17. The external coil 17 sends the electrical stimulation patternsand power via radio-frequency (RF) telemetry to the implanted retinalstimulation system. The internal coil 16 of the retinal stimulationsystem receives the RF commands from the external coil 17 and transmitsthem to the electronics package 14 that in turn delivers stimulation tothe retina via the electrode array 10. Additionally, the retinalstimulation system may communicate safety and operational status back tothe VPU 20 by transmitting RF telemetry from the internal coil 16 to theexternal coil 17. The visual prosthesis apparatus may be configured toelectrically activate the retinal stimulation system only when it ispowered by the VPU 20 through the external coil 17. The stand-alone modemay be used for clinical testing and/or at-home use by the subject.

Communication Mode

The communication mode may be used for diagnostic testing,psychophysical testing, patient fitting and downloading of stimulationsettings to the VPU 20 before transmitting data from the VPU 20 to theretinal stimulation system as is done for example in the stand-alonemode described above. Referring to FIG. 9, in the communication mode,the VPU 20 is connected to the Fitting System laptop 21 using cables 70,45 and the optically isolated serial connection adapter 40. In thismode, laptop 21 generated stimuli may be presented to the subject andprogramming parameters may be adjusted and downloaded to the VPU 20. ThePsychophysical Test System (PTS) laptop 30 connected to the FittingSystem laptop 21 may also be utilized to perform more sophisticatedtesting and analysis as fully described in the related application U.S.application Ser. No. 11/796,425, filed on Apr. 27, 2007, which isincorporated herein by reference in its entirety.

In one embodiment, the functionality of the retinal stimulation systemcan also be tested pre-operatively and intra-operatively (i.e. beforeoperation and during operation) by using an external coil 17, withoutthe glasses 5, placed in close proximity to the retinal stimulationsystem. The coil 17 may communicate the status of the retinalstimulation system to the VPU 20 that is connected to the Fitting Systemlaptop 21 as shown in FIG. 9.

As discussed above, the VPU 20 processes the image from the camera 13and transforms the image into electrical stimulation patterns for theretinal stimulation system. Filters such as edge detection filters maybe applied to the electrical stimulation patterns for example by the VPU20 to generate, for example, a stimulation pattern based on filteredvideo data that the VPU 20 turns into stimulation data for the retinalstimulation system. The images may then be reduced in resolution using adownscaling filter. In one exemplary embodiment, the resolution of theimage may be reduced to match the number of electrodes in the electrodearray 10 of the retinal stimulation system. That is, if the electrodearray has, for example, sixty electrodes, the image may be reduced to asixty channel resolution. After the reduction in resolution, the imageis mapped to stimulation intensity using for example a look-up tablethat has been derived from testing of individual subjects. Then, the VPU20 transmits the stimulation parameters via forward telemetry to theretinal stimulation system in frames that may employ a cyclic redundancycheck (CRC) error detection scheme.

In one exemplary embodiment, the VPU 20 may be configured to allow thesubject/patient i) to turn the visual prosthesis apparatus on and off,ii) to manually adjust settings, and iii) to provide power and data tothe retinal stimulation system. Referring to FIGS. 11 and 12, the VPU 20may comprise a case 800, power button 805 for turning the VPU 20 on andoff, setting button 810, zoom buttons 820 for controlling the camera 13,connector port 815 for connecting to the Glasses 5, a connector port 816for connecting to the laptop 21 through the connection adapter 40,indicator lights 825 to give visual indication of operating status ofthe system, the rechargeable battery 25 for powering the VPU 20, batterylatch 830 for locking the battery 25 in the case 800, digital circuitboards (not shown), and a speaker (not shown) to provide audible alertsto indicate various operational conditions of the system. Because theVPU 20 is used and operated by a person with minimal or no vision, thebuttons on the VPU 20 may be differently shaped and/or have specialmarkings as shown in FIG. 12 to help the user identify the functionalityof the button without having to look at it. As shown in FIG. 12, thepower button 805 may be a circular shape while the settings button 820may be square shape and the zoom buttons 820 may have special raisedmarkings 830 to also identify each buttons' functionality. One skilledin the art would appreciate that other shapes and markings can be usedto identify the buttons without departing from the spirit and scope ofthe invention. For example, the markings can be recessed instead ofraised.

In one embodiment, the indicator lights 825 may indicate that the VPU 20is going through system start-up diagnostic testing when the one or moreindicator lights 825 are blinking fast (more then once per second) andare green in color. The indicator lights 825 may indicate that the VPU20 is operating normally when the one or more indicator lights 825 areblinking once per second and are green in color. The indicator lights825 may indicate that the retinal stimulation system has a problem thatwas detected by the VPU 20 at start-up diagnostic when the one or moreindicator lights 825 are blinking for example once per five second andare green in color. The indicator lights 825 may indicate that the videosignal from camera 13 is not being received by the VPU 20 when the oneor more indicator lights 825 are always on and are amber color. Theindicator lights 825 may indicate that there is a loss of communicationbetween the retinal stimulation system and the external coil 17 due tothe movement or removal of Glasses 5 while the system is operational orif the VPU 20 detects a problem with the retinal stimulation system andshuts off power to the retinal stimulation system when the one or moreindicator lights 825 are always on and are orange color. One skilled inthe art would appreciate that other colors and blinking patterns can beused to give visual indication of operating status of the system withoutdeparting from the spirit and scope of the invention.

In one embodiment, a single short beep from the speaker (not shown) maybe used to indicate that one of the buttons 825, 805 or 810 have beenpressed. A single beep followed by two more beeps from the speaker (notshown) may be used to indicate that VPU 20 is turned off. Two beeps fromthe speaker (not shown) may be used to indicate that VPU 20 is startingup. Three beeps from the speaker (not shown) may be used to indicatethat an error has occurred and the VPU 20 is about to shut downautomatically. As would be clear to one skilled in the art, differentperiodic beeping may also be used to indicate a low battery voltagewarning, that there is a problem with the video signal, and/or there isa loss of communication between the retinal stimulation system and theexternal coil 17. One skilled in the art would appreciate that othersounds can be used to give audio indication of operating status of thesystem without departing from the spirit and scope of the invention. Forexample, the beeps may be replaced by an actual prerecorded voiceindicating operating status of the system.

In one exemplary embodiment, the VPU 20 is in constant communicationwith the retinal stimulation system through forward and backwardtelemetry. In this document, the forward telemetry refers totransmission from VPU 20 to the retinal stimulation system and thebackward telemetry refers to transmissions from the Retinal stimulationsystem to the VPU 20. During the initial setup, the VPU 20 may transmitnull frames (containing no stimulation information) until the VPU 20synchronizes with the Retinal stimulation system via the back telemetry.In one embodiment, an audio alarm may be used to indicate whenever thesynchronization has been lost.

In order to supply power and data to the Retinal stimulation system, theVPU 20 may drive the external coil 17, for example, with a 3 MHz signal.To protect the subject, the retinal stimulation system may comprise afailure detection circuit to detect direct current leakage and to notifythe VPU 20 through back telemetry so that the visual prosthesisapparatus can be shut down.

The forward telemetry data (transmitted for example at 122.76 kHz) maybe modulated onto the exemplary 3 MHz carrier using Amplitude ShiftKeying (ASK), while the back telemetry data (transmitted for example at3.8 kHz) may be modulated using Frequency Shift Keying (FSK) with, forexample, 442 kHz and 457 kHz. The theoretical bit error rates can becalculated for both the ASK and FSK scheme assuming a ratio of signal tonoise (SNR). The system disclosed in the present disclosure can bereasonably expected to see bit error rates of 10⁻⁵ on forward telemetryand 10⁻³ on back telemetry. These errors may be caught more than 99.998%of the time by both an ASIC hardware telemetry error detection algorithmand the VPU 20's firmware. For the forward telemetry, this is due to thefact that a 16-bit cyclic redundancy check (CRC) is calculated for every1024 bits sent to the ASIC within electronics package 14 of the RetinalStimulation System. The ASIC of the Retinal Stimulation System verifiesthis CRC and handles corrupt data by entering a non-stimulating ‘safe’state and reporting that a telemetry error was detected to the VPU 20via back telemetry. During the ‘safe’ mode, the VPU 20 may attempt toreturn the implant to an operating state. This recovery may be on theorder of milliseconds. The back telemetry words are checked for a 16-bitheader and a single parity bit. For further protection against corruptdata being misread, the back telemetry is only checked for header andparity if it is recognized as properly encoded Biphase Mark Encoded(BPM) data. If the VPU 20 detects invalid back telemetry data, the VPU20 immediately changes mode to a ‘safe’ mode where the RetinalStimulation System is reset and the VPU 20 only sends non-stimulatingdata frames. Back telemetry errors cannot cause the VPU 20 to doanything that would be unsafe.

The response to errors detected in data transmitted by VPU 20 may beginat the ASIC of the Retinal Stimulation System. The Retinal StimulationSystem may be constantly checking the headers and CRCs of incoming dataframes. If either the header or CRC check fails, the ASIC of the RetinalStimulation System may enter a mode called LOSS OF SYNC 950, shown inFIG. 13a . In LOSS OF SYNC mode 950, the Retinal Stimulation System willno longer produce a stimulation output, even if commanded to do so bythe VPU 20. This cessation of stimulation occurs after the end of thestimulation frame in which the LOSS OF SYNC mode 950 is entered, thusavoiding the possibility of unbalanced pulses not completingstimulation. If the Retinal Stimulation System remains in a LOSS OF SYNCmode 950 for 1 second or more (for example, caused by successive errorsin data transmitted by VPU 20), the ASIC of the Retinal StimulationSystem disconnects the power lines to the stimulation pulse drivers.This eliminates the possibility of any leakage from the power supply ina prolonged LOSS OF SYNC mode 950. From the LOSS OF SYNC mode 950, theRetinal Stimulation System will not re-enter a stimulating mode until ithas been properly initialized with valid data transmitted by the VPU 20.

In addition, the VPU 20 may also take action when notified of the LOSSOF SYNC mode 950. As soon as the Retinal Stimulation System enters theLOSS OF SYNC mode 950, the Retinal Stimulation System reports this factto the VPU 20 through back telemetry. When the VPU 20 detects that theRetinal Stimulation System is in LOSS OF SYNC mode 950, the VPU 20 maystart to send ‘safe’ data frames to the Retinal Stimulation System.‘Safe’ data is data in which no stimulation output is programmed and thepower to the stimulation drivers is also programmed to be off. The VPU20 will not send data frames to the Retinal Stimulation System withstimulation commands until the VPU 20 first receives back telemetry fromthe Retinal Stimulation System indicating that the Retinal StimulationSystem has exited the LOSS OF SYNC mode 950. After several unsuccessfulretries by the VPU 20 to take the implant out of LOSS OF SYNC mode 950,the VPU 20 will enter a Low Power Mode (described below) in which theimplant is only powered for a very short time. In this time, the VPU 20checks the status of the implant. If the implant continues to report aLOSS OF SYNC mode 950, the VPU 20 turns power off to the RetinalStimulation System and tries again later. Since there is no possibilityof the implant electronics causing damage when it is not powered, thismode is considered very safe.

Due to an unwanted electromagnetic interference (EMI) or electrostaticdischarge (ESD) event the VPU 20 data, specifically the VPU firmwarecode, in RAM can potentially get corrupted and may cause the VPU 20firmware to freeze. As a result, the VPU 20 firmware will stop resettingthe hardware watchdog circuit, which may cause the system to reset. Thiswill cause the watchdog timer to expire causing a system reset in, forexample, less than 2.25 seconds. Upon recovering from the reset, the VPU20 firmware logs the event and shuts itself down. VPU 20 will not allowsystem usage after this occurs once. This prevents the VPU 20 code fromfreezing for extended periods of time and hence reduces the probabilityof the VPU sending invalid data frames to the implant.

Supplying power to the Retinal stimulation system can be a significantportion of the VPU 20's total power consumption. When the Retinalstimulation system is not within receiving range to receive either poweror data from the VPU 20, the power used by the VPU 20 is wasted.

Power delivered to the Retinal stimulation system may be dependent onthe orientation of the coils 17 and 16. The power delivered to theRetinal stimulation system may be controlled, for example, via the VPU20 every 16.6 ms. The Retinal stimulation system may report how muchpower it receives and the VPU 20 may adjust the power supply voltage ofthe RF driver to maintain a required power level on the Retinalstimulation system. Two types of power loss may occur: 1) long term (>˜1second) and 2) short term (<˜1 second). The long term power loss may becaused, for example, by a subject removing the Glasses 5.

In one exemplary embodiment, the Low Power Mode may be implemented tosave power for VPU 20. The Low Power Mode may be entered, for example,anytime the VPU 20 does not receive back telemetry from the Retinalstimulation system. Upon entry to the Low Power Mode, the VPU 20 turnsoff power to the Retinal stimulation system. After that, andperiodically, the VPU 20 turns power back on to the Retinal stimulationsystem for an amount of time just long enough for the presence of theRetinal stimulation system to be recognized via its back telemetry. Ifthe Retinal stimulation system is not immediately recognized, thecontroller again shuts off power to the Retinal stimulation system. Inthis way, the controller ‘polls’ for the passive Retinal stimulationsystem and a significant reduction in power used is seen when theRetinal stimulation system is too far away from its controller device.FIG. 13b depicts an exemplary block diagram 900 of the steps taken whenthe VPU 20 does not receive back telemetry from the Retinal stimulationsystem. If the VPU 20 receives back telemetry from the Retinalstimulation system (output “YES” of step 901), the Retinal stimulationsystem may be provided with power and data (step 906). If the VPU 20does not receive back telemetry from the Retinal stimulation system(output “NO” of step 901), the power to the Retinal stimulation systemmay be turned off. After some amount of time, power to the Retinalstimulation system may be turned on again for enough time to determineif the Retinal stimulation system is again transmitting back telemetry(step 903). If the Retinal stimulation system is again transmitting backtelemetry (step 904), the Retinal stimulation system is provided withpower and data (step 906). If the Retinal stimulation system is nottransmitting back telemetry (step 904), the power to the Retinalstimulation system may again be turned off for a predetermined amount oftime (step 905) and the process may be repeated until the Retinalstimulation system is again transmitting back telemetry.

In another exemplary embodiment, the Low Power Mode may be enteredwhenever the subject is not wearing the Glasses 5. In one example, theGlasses 5 may contain a capacitive touch sensor (not shown) to providethe VPU 20 digital information regarding whether or not the Glasses 5are being worn by the subject. In this example, the Low Power Mode maybe entered whenever the capacitive touch sensor detects that the subjectis not wearing the Glasses 5. That is, if the subject removes theGlasses 5, the VPU 20 will shut off power to the external coil 17. Assoon as the Glasses 5 are put back on, the VPU 20 will resume poweringthe external coil 17. FIG. 13c depicts an exemplary block diagram 910 ofthe steps taken when the capacitive touch sensor detects that thesubject is not wearing the Glasses 5. If the subject is wearing Glasses5 (step 911), the Retinal stimulation system is provided with power anddata (step 913). If the subject is not wearing Glasses 5 (step 911), thepower to the Retinal stimulation system is turned off (step 912) and theprocess is repeated until the subject is wearing Glasses 5.

One exemplary embodiment of the VPU 20 is shown in FIG. 14. The VPU 20may comprise: a Power Supply, a Distribution and Monitoring Circuit(PSDM) 1005, a Reset Circuit 1010, a System Main Clock (SMC) source (notshown), a Video Preprocessor Clock (VPC) source (not shown), a DigitalSignal Processor (DSP) 1020, Video Preprocessor Data Interface 1025, aVideo Preprocessor 1075, an PC Protocol Controller 1030, a ComplexProgrammable Logic device (CPLD) (not shown), a Forward TelemetryController (FTC) 1035, a Back Telemetry Controller (BTC) 1040,Input/Output Ports 1045, Memory Devices like a Parallel Flash Memory(PFM) 1050 and a Serial Flash Memory (SFM) 1055, a Real Time Clock 1060,an RF Voltage and Current Monitoring Circuit (VIMC) (not shown), aspeaker and/or a buzzer, an RF receiver 1065, and an RF transmitter1070.

The Power Supply, Distribution and Monitoring Circuit (PSDM) 1005 mayregulate a variable battery voltage to several stable voltages thatapply to components of the VPU 20. The Power Supply, Distribution andMonitoring Circuit (PSDM) 1005 may also provide low battery monitoringand depleted battery system cutoff. The Reset Circuit 1010 may havereset inputs 1011 that are able to invoke system level rest. Forexample, the reset inputs 1011 may be from a manual push-button reset, awatchdog timer expiration, and/or firmware based shutdown. The SystemMain Clock (SMC) source is a clock source for DSP 1020 and CPLD. TheVideo Preprocessor Clock (VPC) source is a clock source for the VideoProcessor. The DSP 1020 may act as the central processing unit of theVPU 20. The DSP 1020 may communicate with the rest of the components ofthe VPU 20 through parallel and serial interfaces. The Video Processor1075 may convert the NTSC signal from the camera 13 into a down-scaledresolution digital image format. The Video Processor 1075 may comprise avideo decoder (not shown) for converting the NTSC signal intohigh-resolution digitized image and a video scaler (not shown) forscaling down the high-resolution digitized image from the video decoderto an intermediate digitized image resolution. The video decoder may becomposed of an Analog Input Processing, Chrominance and LuminanceProcessing and Brightness Contrast and Saturation (BSC) Controlcircuits. The video scaler may be composed of Acquisition control,Pre-scaler, BSC-control, Line Buffer and Output Interface. The I²CProtocol Controller 1030 may serve as a link between the DSP 1020 andthe I²C bus. The I²C Protocol Controller 1030 may be able to convert theparallel bus interface of the DSP 1020 to the I²C protocol bus or viceversa. The I²C Protocol Controller 1030 may also be connected to theVideo Processor 1075 and the Real Time Clock 1060. The VPDI 1025 maycontain a tri-state machine to shift video data from Video Preprocessor1075 to the DSP 1020. The Forward Telemetry Controller (FTC) 1035 packs1024 bits of forward telemetry data into a forward telemetry frame. TheFTC 1035 retrieves the forward telemetry data from the DSP 1020 andconverts the data from logic level to biphase marked data. The BackTelemetry Controller (BTC) 1040 retrieves the biphase marked data fromthe RF receiver 1065, decodes it, and generates the BFSR, BCLKR and BDRfor the DSP 1020. The Input/Output Ports 1045 provide expanded IOfunctions to access the CPLD on-chip and off-chip devices. The ParallelFlash Memory (PFM) 1050 may be used to store executable code and theSerial Flash Memory (SFM) 1055 may provide Serial Port Interface (SPI)for data storage. The VIMC may be used to sample and monitor RFtransmitter 1070 current and voltage in order to monitor the integritystatus of the retinal stimulation system.

Accordingly, what has been shown is an improved visual prosthesis and animproved method for limiting power consumption in a visual prosthesis.While the invention has been described by means of specific embodimentsand applications thereof, it is understood that numerous modificationsand variations could be made thereto by those skilled in the art withoutdeparting from the spirit and scope of the invention. It is therefore tobe understood that within the scope of the claims, the invention may bepracticed otherwise than as specifically described herein.

What is claimed is:
 1. A method of fitting an implantable neuralstimulator comprising in order the steps of: a. providing an implantableneural stimulator including electrical components and an array ofelectrodes suitable to stimulate visual neurons; b. providing acomputer, the computer completing steps c through 1 under automaticcontrol of the computer; c. beginning recording electrically evokedresponse levels of measured neural activity; d. stimulating the visualneurons with a series of electrical stimulation signals through aselected subset of the array of electrodes; e. Stopping the recordingelectrically evoked response levels of measured neural activity; f.filtering the response signals; g. applying a wavelet transform to theresponse signals to filter out any artifacts caused by the electricalcomponents in the implantable neural stimulator; h. discarding theresponse signals with large artifacts; i. averaging response signalsmeasured during multiple epochs; j. comparing each level of the responsesignals to each level of the stimulation signals; k. determining arelationship between the each level of the stimulation signals and eachlevel of the response signals; l. repeating steps c-k for differentselected subsets of the array of electrodes; m. determining and storingdesired levels of stimulation based upon the comparison of the levels ofthe response signals and the levels of the stimulation signals; and m.stimulating the visual neurons with the implantable neural stimulator toinduce the perception of vision based on the desired levels ofstimulation signals.
 2. The method according to claim 1, wherein thestep of stimulating the visual neurons includes increasing theelectrical charge of the electrical stimulation signals until the neuralactivity is detected.
 3. The method according to claim 1, wherein saidstep of stimulating the visual neurons includes decreasing theelectrical stimulation signals when a predetermined level of the neuralactivity is reached.
 4. The method according to claim 1, furthercomprising analysis of the delay period between the step of stimulatingthe visual neurons and the measurement of the neural activity, whereinthe delay period varies according to a level of input stimulus, and thisvariation is used in the fitting process.
 5. The method according toclaim 1, wherein storing a level of stimulation includes storing athreshold for each electrode in the array of electrodes.
 6. The methodaccording to claim 1, further comprising ignoring the neural activitygreater than a predetermined voltage.
 7. The method according to claim6, wherein the predetermined voltage is between 40 μV and 60 μV.